Journal Exposes Enriched Doctors Who Downplayed Product’s Side Effects

A medical publication, The Spine Journal, is showing some extraordinary backbone.

In a rare and possibly unprecedented move, the journal’s editors have dedicated an entire issue to exposing apparent wrongdoing involving doctors who took tens of millions of dollars from a medical device maker, Medtronic — and then downplayed or ignored serious complications linked to one of the company’s products.

The Spine Journal reported that that Medtronic paid surgeons who co-authored 13 evaluations of its back surgery product, Infuse, a median of $12 million to $16 million per study. The studies were carried out on Infuse, a protein used to replace real bone during spinal fusion surgery, over nearly 10 years.

The medical journal’s editors found a systematic failure among the Medtronics-paid researchers to report serious complications ranging from increased risk of cancer to  inflammatory reactions and fertility problems.  Moreover, actual complication rates were 10 to 50 times higher than those estimated in the articles by the doctors paid millions by Medtronic, the editors said.

“None of the original estimates of safety … proved accurate,” said an editorial published in the journal. The editorial added: “Sterility or cancer risks, which were prominently discussed in Food and Drug Administration documents and hearings, did not receive one line of discussion in the industry-sponsored publications of those trials.”

The Spine Journal’s coverage follows its publication last month of recent studies linking Infuse to male infertility.

In an article published jointly by the Milwaukee Journal Sentinel and MedPage Today, Medtronic officials were quoted as saying they are investigating whether published papers failed to properly disclose complications linked to Infuse.

“We are very serious about this,” said Richard Kuntz, Medtronic’s senior vice president and chief scientific, clinical and regulatory officer. “We will do a full analysis of these papers.”

In a prepared statement, Medtronic’s chief executive, Omar Ishrak, said he strongly believes in the safety of Infuse as supported by data provided to the FDA and on the product’s label.

“While the Spine Journal articles raise questions about researchers’ conclusions in their peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to the physicians today through the instructions for use brochure attached to each product sold,” he said.

One of the physicians who performed the research in question, Dr. Thomas Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health, received $23 million in royalties and other payments from Medtronic. The Journal Sentinel and MedPage Today account said he declined to comment.

Related Posts:
Senators Probe Whether Medtronic Consultants Ignored Harmful Side Effects
Surgical Product Might Cause Sterility, Stanford Researcher Says

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